Quality Assurance Director

New

Skills

Analytical Thinking Compliance Cross-functional Collaboration Process Improvement Training

Job Overview

Lead GVP quality and compliance program across BridgeBio affiliates. Advise stakeholders on US/EU PV regulations, policies, and SOPs. Oversee PV audits, CAPA, and audit reporting. Collaborate with affiliates to improve PV processes and training.

Responsibilities
  • Lead GVP quality and compliance program
  • Advise stakeholders on regulations and policies
  • Oversee PV audits, CAPA, and reporting
  • Collaborate with affiliates on process improvement
Requirements & Qualifications
  • 10-15+ years in GVP quality/compliance in biotech or CRO
  • Bachelor’s degree in a related field
  • Global GVP regs knowledge: CFR, EMA, MHRA, ICH
  • Strong cross-functional collaboration skills
  • Analytical thinker with strong business communication

Job Type: Remote

Salary: Not Disclosed

Experience: Entry

Duration: 12 Months

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